{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYPROMELLOSE 2208 (15000 MPA.S) MICROCRYSTALLINE CELLULOSE LACTOSE MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE white to off white FM4 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE LACTOSE MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2208 (15000 MPA.S) MICROCRYSTALLINE CELLULOSE white to off white FM5" ], "boxed_warning": [ "WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) , Drug Abuse and Dependence ( 9.2 , 9.3 )] . WARNING: ABUSE, MISUSE AND ADDICTION See full prescribing information for complete boxed warning. Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ). • Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction. • Educate patients and their families about these risks, proper storage of methylphenidate hydrochloride extended-release tablets, and proper disposal of any unused drug. • Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction." ], "recent_major_changes": [ "Contraindications ( 4 ) 07/2026" ], "indications_and_usage": [ "1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: Attention deficit hyperactivity disorder (ADHD) Narcolepsy Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ] . Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of adults and pediatric patients 6 years and older ( 1 ): • Attention deficit hyperactivity disorder (ADHD) and • Narcolepsy. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 )." ], "dosage_and_administration": [ "2 DOSAGE AND ADMINISTRATION N/A • Prior to initiating methylphenidate hydrochloride extended-release tablets treatment, assess each patient’s risk for ( 2.1 ): o Abuse, misuse, and addiction ( 5.1 ) o Presence of cardiac disease ( 5.2 ) o Developing a manic episode ( 5.4 ) o A family history of tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette syndrome • See the recommended dosage and administration in the Full Prescribing Information ( 2 ) • Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets. 2.1 Pretreatment Screening Prior to treating patients with Methylphenidate hydrochloride extended-release tablets, assess: • The risk for abuse, misuse, and addiction [see Warnings and Precautions (5.1) ] . • For the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . • The risk for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) [see Warnings and Precautions (5.4) ] . • For a family history for tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions (5.10) ] 2.2 Recommended Dosage In pediatric patients 6 years of age and older, start with an immediate-release methylphenidate product 5 mg orally twice daily. Subsequently, switch to methylphenidate hydrochloride extended-release tablets 10 mg once daily. May gradually increase the methylphenidate hydrochloride extended-release tablets dosage. The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in pediatric patients 6 years of age and older is 60 mg per day. In adult patients, the recommended oral dosage of methylphenidate hydrochloride extended-release tablets is 20 mg or 30 mg daily. The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in adults is 60 mg per day. Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets. 2.3 Dosage Reduction and Discontinuation If paradoxical aggravation of ADHD or narcolepsy symptoms or methylphenidate hydrochloride extended-release tablets-associated adverse reactions occur, reduce the methylphenidate hydrochloride extended-release tablets dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release tablets. If improvement is not observed after appropriate dosage modification over a one-month period, discontinue methylphenidate hydrochloride extended-release tablets. 2.4 Starting Methylphenidate Hydrochloride Extended-Release Tablets After Use of a Monoamine Oxidase Inhibitor Must wait at least 14 days after stopping a monoamine oxidase (MAO) inhibitor before starting methylphenidate hydrochloride extended-release tablets [see Contraindications (4) and Drug Interactions (7) ] ." ], "dosage_forms_and_strengths": [ "3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 10 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and plain on other side. 20 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and plain on other side. Extended-release tablets: 10 mg and 20 mg ( 3 )" ], "contraindications": [ "4 CONTRAINDICATIONS Methylphenidate Hydrochloride Extended-Release Tablets are contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ see Adverse Reactions (6) ]. Receiving concomitant monoamine oxidase inhibitors (MAOIs), or those that discontinued treatment with an MAOI in the last 14 days, because of the risk of hypertensive crises [ see Drug Interactions (7) ]. Patients with pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received an amphetamine product. Methylphenidate hydrochloride extended-release tablets are contraindicated in patients ( 4 ): With known hypersensitivity to methylphenidate or other product components of Methylphenidate hydrochloride extended-release tablets. (4) Receiving concomitant monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4) . Patients with pheochromocytoma or a history of pheochromocytoma ( 4 )" ], "warnings_and_cautions": [ "5 WARNINGS AND PRECAUTIONS N/A • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse ( 5.3 ). • Psychiatric Adverse Reactions: If new psychotic or manic symptoms occur, consider discontinuing Methylphenidate hydrochloride extended-release Tablets. ( 5.4 ) • Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ) • Peripheral Vasculopathy, including Raynaud's Phenomenon: Carefully assess for digital changes during Methylphenidate hydrochloride extended-release tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ) • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their Methylphenidate hydrochloride extended-release tablets treatment interrupted. ( 5.7 ) • Acute Angle Closure Glaucoma: Methylphenidate hydrochloride extended-release Tablets-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.8 ) • Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe Methylphenidate hydrochloride extended-release Tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. ( 5.9 ) • Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Regularly monitor patients for the emergence or Methylphenidate hydrochloride extended-release tablets worsening of tics or Tourette's syndrome. Discontinue Methylphenidate hydrochloride extended-release tablets treatment if clinically appropriate. ( 5.10 ) 5.1 Abuse, Misuse, and Addiction Methylphenidate hydrochloride extended-release tablets has a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see Drug Abuse and Dependence ( 9.1 , 9.2 )] . Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Prior to treating patients with methylphenidate hydrochloride extended-release tablets, assess for the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Avoid methylphenidate hydrochloride extended-release tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute) [see Adverse Reactions (6) ] . Some patients may have larger increases. Monitor all methylphenidate hydrochloride extended-release tablets-treated patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis in Patients with a Psychotic Disorder CNS stimulants, including methylphenidate hydrochloride extended-release tablets, may exacerbate behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants, including methylphenidate hydrochloride extended-release tablets, may induce a manic or mixed mood episode in patients with bipolar disorder. Prior to initiating methylphenidate hydrochloride extended-release tablets treatment, screen patients for risk factors for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms in Patients without a History of a Bipolar or Psychotic Disorder CNS stimulants (including methylphenidate hydrochloride extended-release tablets), at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release tablets. 5.5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in adult and pediatric male patients [see Adverse Reactions (6)]. Although priapism was not reported with methylphenidate initiation, priapism occurred in patients treated with methylphenidate but developed after some time., often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. Methylphenidate hydrochloride extended-release tablets-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. 5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon CNS stimulants, including methylphenidate hydrochloride extended-release tablets used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon [see Adverse Reactions (6) ] . Signs and symptoms of these cases of peripheral vasculopathy were usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at a therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms of these cases of peripheral vasculopathy generally improved after CNS stimulant dosage reduction or discontinuation of drug. During methylphenidate hydrochloride extended-release tablets treatment, carefully assess for digital changes. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for methylphenidate hydrochloride extended-release tablets-treated patients who develop signs or symptoms of peripheral vasculopathy. 5.7 Long-Term Suppression of Growth in Pediatric Patients Methylphenidate hydrochloride extended-release tablets are not approved for use and are not recommended in pediatric patients below 6 years of age [see Use in Specific Populations (8.4) ] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients treated with methylphenidate (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Closely monitor growth (weight and height) in methylphenidate hydrochloride extended-release tablets-treated pediatric patients. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 5.8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, methylphenidate hydrochloride extended-release tablets-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. 5.9 Increased Intraocular Pressure and Glaucoma There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6) ] . Prescribe methylphenidate hydrochloride extended-release tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor methylphenidate hydrochloride extended-release tablets-treated patients with a history of abnormally increased IOP or open angle glaucoma. 5.10 Motor and Verbal Tics, and Worsening of Tourette's Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics [see Adverse Reactions (6) ] . Worsening of Tourette's syndrome has also been reported. Before initiating methylphenidate hydrochloride extended-release tablets, assess the family history for tics or Tourette' syndrome and clinically evaluate patients for tics or Tourette's syndrome. Regularly monitor methylphenidate hydrochloride extended-release tablets-treated patients for the emergence or worsening of tics or Tourette's syndrome, and discontinue methylphenidate hydrochloride extended-release tablets treatment if clinically appropriate." ], "adverse_reactions": [ "6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2 ) ] Hypersensitivity Reactions [ see Contraindications (4) ] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Priapism [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.6) ] Long-term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.10) ] The following adverse reactions associated with the use of methylphenidate were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported with Methylphenidate Hydrochloride Extended-Release Tablets • Infections and Infestations: nasopharyngitis • Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia, anemia • Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis • Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients • Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood • Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs • Eye Disorders: blurred vision, difficulties in visual accommodation • Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris • Respiratory, Thoracic and Mediastinal Disorders: cough • Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia • Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury • Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura • Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis • Investigations: weight loss (adult ADHD patients) Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions reported with other methylphenidate-containing products. • Blood and Lymphatic Disorders: pancytopenia • Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas • Psychiatric Disorders: affect lability, mania, disorientation and libido changes • Nervous System Disorders: migraine • Eye Disorders: diplopia, mydriasis • Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole • Vascular Disorders: peripheral coldness, Raynaud's phenomenon • Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea • Gastrointestinal Disorders: diarrhea, constipation • Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption • Musculoskeletal, Connective Tissue and bone Disorders: myalgia, muscle twitching • Renal and Urinary Disorders: hematuria • Reproductive System and Breast Disorders: gynecomastia • General Disorders: fatigue, hyperpyrexia • Urogenital Disorders : priapism Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3138 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch." ], "drug_interactions": [ "7 DRUG INTERACTIONS Table 1 presents clinically significant drug interactions with methylphenidate hydrochloride extended-release tablets. Table 1: Clinically Significant Drug Interactions with Methylphenidate Hydrochloride Extended-Release Tablets Monoamine Oxidase Inhibitors (MAOI) Prevention or Management Concomitant use of methylphenidate hydrochloride extended-release tablets with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [see Contraindications (4) ] . Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) Methylphenidate hydrochloride extended-release tablets may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ] . Halogenated Anesthetics Prevention or Management Avoid use of methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of methylphenidate hydrochloride extended-release tablets and halogenated anesthetics may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms. Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant methylphenidate hydrochloride extended-release tablets when there is a change in the methylphenidate hydrochloride extended-release tablets or risperidone dosage. Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7) See additional clinically significant drug interactions, in the DRUG INTERACTIONS section ( 7 )." ], "drug_interactions_table": [ "
Monoamine Oxidase Inhibitors (MAOI)
Prevention or ManagementConcomitant use of methylphenidate hydrochloride extended-release tablets with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [see Contraindications (4)] .
Mechanism and Clinical Effect(s)Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Antihypertensive Drugs
Prevention or ManagementIncrease monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed.
Mechanism and Clinical Effect(s)Methylphenidate hydrochloride extended-release tablets may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3] .
Halogenated Anesthetics
Prevention or ManagementAvoid use of methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery.
Mechanism and Clinical Effect(s)Concomitant use of methylphenidate hydrochloride extended-release tablets and halogenated anesthetics may increase the risk of sudden blood pressure and heart rate increase during surgery.
Risperidone
Prevention or ManagementMonitor for signs of extrapyramidal symptoms.
Mechanism and Clinical Effect(s)The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant methylphenidate hydrochloride extended-release tablets when there is a change in the methylphenidate hydrochloride extended-release tablets or risperidone dosage.
" ], "use_in_specific_populations": [ "8 USE IN SPECIFIC POPULATIONS N/A 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of CNS stimulants use during pregnancy [see Clinical Considerations] . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The background risk of major birth defects and miscarriage in those with ADHD or narcolepsy is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as Methylphenidate hydrochloride extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Data Animal In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis). 8.2 Lactation Risk Summary Limited published literature, based on milk sampling from a small number of methylphenidate-treated lactating women, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Methylphenidate hydrochloride extended-release tablets and any potential adverse effects on the breastfed infant from Methylphenidate hydrochloride extended-release tablets or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants of methylphenidate hydrochloride extended-release tablets-treated lactating women for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 8.4 Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of ADHD and narcolepsy have been established in pediatric patients 6 years of age and older. The safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored during treatment with CNS stimulants, including Methylphenidate hydrochloride extended-release tablets. Pediatric patients who are not growing or gaining weight as expected may need to have their methylphenidate hydrochloride extended-release tablets treatment interrupted [ see Warnings and Precautions (5.7) ] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown. 8.5 Geriatric Use Methylphenidate hydrochloride tablet has not been studied in the geriatric population." ], "pregnancy": [ "8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of CNS stimulants use during pregnancy [see Clinical Considerations] . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The background risk of major birth defects and miscarriage in those with ADHD or narcolepsy is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as Methylphenidate hydrochloride extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Data Animal In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis)." ], "pediatric_use": [ "8.4 Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of ADHD and narcolepsy have been established in pediatric patients 6 years of age and older. The safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored during treatment with CNS stimulants, including Methylphenidate hydrochloride extended-release tablets. Pediatric patients who are not growing or gaining weight as expected may need to have their methylphenidate hydrochloride extended-release tablets treatment interrupted [ see Warnings and Precautions (5.7) ] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown." ], "geriatric_use": [ "8.5 Geriatric Use Methylphenidate hydrochloride tablet has not been studied in the geriatric population." ], "drug_abuse_and_dependence": [ "9 DRUG ABUSE AND DEPENDENCE N/A 9.1 Controlled Substance Methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a Schedule II controlled substance. 9.2 Abuse Methylphenidate hydrochloride extended-release tablets have a high potential for abuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Methylphenidate hydrochloride extended-release tablets has a high potential for misuse. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Misuse, like abuse, is often associated with higher doses and/or more frequent use of the drug, which may lead to adverse reactions similar to those seen in the context of abuse and substance use disorder. Misuse and abuse of methylphenidate hydrochloride extended-release tablets may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. 9.3 Dependence Physical Dependence Methylphenidate hydrochloride extended-release tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dosage reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride extended-release tablets included dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride extended-release tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose)." ], "controlled_substance": [ "9.1 Controlled Substance Methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a Schedule II controlled substance." ], "abuse": [ "9.2 Abuse Methylphenidate hydrochloride extended-release tablets have a high potential for abuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Methylphenidate hydrochloride extended-release tablets has a high potential for misuse. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Misuse, like abuse, is often associated with higher doses and/or more frequent use of the drug, which may lead to adverse reactions similar to those seen in the context of abuse and substance use disorder. Misuse and abuse of methylphenidate hydrochloride extended-release tablets may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection." ], "dependence": [ "9.3 Dependence Physical Dependence Methylphenidate hydrochloride extended-release tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dosage reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride extended-release tablets included dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride extended-release tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose)." ], "overdosage": [ "10 OVERDOSAGE Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis. Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI). Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations. 10.1 Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. • Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI). 10.2 Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release tablets should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations." ], "description": [ "11 DESCRIPTION Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str" ], "clinical_pharmacology": [ "12 CLINICAL PHARMACOLOGY N/A 12.1 Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space. 12.2 Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been fully characterized. Cardiac Electrophysiology A formal QT study has not been conducted in patients who received Methylphenidate hydrochloride extended-release tablets. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Methylphenidate hydrochloride tablets on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval (CI) was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship. 12.3 Pharmacokinetics Absorption Methylphenidate hydrochloride in methylphenidate hydrochloride extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the Methylphenidate hydrochloride tablet measured by the urinary excretion of Methylphenidate hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Methylphenidate hydrochloride tablets and 4.7 hours (1.3 to 8.2 hours) for the Methylphenidate hydrochloride extended-release tablets. An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults. Effect of Food: After a high-fat meal, both area under the curve (AUC) (by 25%) and C max (by 27%) are higher. Time to C max (T max ) is faster after a high-fat meal (median T max : 2.5 hours) as compared to without food (median T max : 3 hours). Distribution Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ± 1.11 L/kg for d-methylphenidate and 1.8 ± 0.91 L/kg for l-methylphenidate. Elimination The systemic clearance is 0.4 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate. Metabolism: Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion: After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours. Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for Methylphenidate hydrochloride extended-release tablets. Studies in Specific Populations Male and Female Patients: In a clinical study involving adult subjects who received Methylphenidate hydrochloride extended-release tablets plasma concentrations of Methylphenidate hydrochloride's major metabolite appeared to be greater in females than in males. No gender differences were observed for Methylphenidate hydrochloride plasma concentration in the same subjects. Racial or Ethnic Groups: There is insufficient experience with the use of Methylphenidate hydrochloride extended-release tablets to detect ethnic variations in pharmacokinetics. Patients with Renal Impairment: Methylphenidate hydrochloride has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity. Patients with Hepatic Impairment: Methylphenidate hydrochloride has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body." ], "mechanism_of_action": [ "12.1 Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space." ], "pharmacodynamics": [ "12.2 Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been fully characterized. Cardiac Electrophysiology A formal QT study has not been conducted in patients who received Methylphenidate hydrochloride extended-release tablets. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Methylphenidate hydrochloride tablets on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval (CI) was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship." ], "pharmacokinetics": [ "12.3 Pharmacokinetics Absorption Methylphenidate hydrochloride in methylphenidate hydrochloride extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the Methylphenidate hydrochloride tablet measured by the urinary excretion of Methylphenidate hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Methylphenidate hydrochloride tablets and 4.7 hours (1.3 to 8.2 hours) for the Methylphenidate hydrochloride extended-release tablets. An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults. Effect of Food: After a high-fat meal, both area under the curve (AUC) (by 25%) and C max (by 27%) are higher. Time to C max (T max ) is faster after a high-fat meal (median T max : 2.5 hours) as compared to without food (median T max : 3 hours). Distribution Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ± 1.11 L/kg for d-methylphenidate and 1.8 ± 0.91 L/kg for l-methylphenidate. Elimination The systemic clearance is 0.4 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate. Metabolism: Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion: After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours. Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for Methylphenidate hydrochloride extended-release tablets. Studies in Specific Populations Male and Female Patients: In a clinical study involving adult subjects who received Methylphenidate hydrochloride extended-release tablets plasma concentrations of Methylphenidate hydrochloride's major metabolite appeared to be greater in females than in males. No gender differences were observed for Methylphenidate hydrochloride plasma concentration in the same subjects. Racial or Ethnic Groups: There is insufficient experience with the use of Methylphenidate hydrochloride extended-release tablets to detect ethnic variations in pharmacokinetics. Patients with Renal Impairment: Methylphenidate hydrochloride has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity. Patients with Hepatic Impairment: Methylphenidate hydrochloride has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body." ], "nonclinical_toxicology": [ "13 NONCLINICAL TOXICOLOGY N/A 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/day given to children on mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) on a mg/m 2 basis. In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/day given to children on mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) on a mg/m 2 basis. In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis." ], "how_supplied": [ "16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate hydrochloride extended-release tablets, USP are available as follows: 10 mg: White to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and plain on other side. Bottles of 30 tablets NDC 70010-042-03 Bottles of 100 tablets NDC 70010-042-01 20 mg: White to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and plain on other side. Bottles of 30 tablets NDC 70010-043-03 Bottles of 100 tablets NDC 70010-043-01 NOTE : Methylphenidate hydrochloride extended-release tablets, USP are color-additive free. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure." ], "information_for_patients": [ "17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride extended-release tablets, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence ( 9.1 , 9.2 ), Overdosage (10) ] . Advise patients to store methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with Methylphenidate hydrochloride extended-release tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [ see Warnings and Precautions (5.2) ]. Increased Blood Pressure and Heart Rate Advise patients and their caregivers that Methylphenidate hydrochloride extended-release tablets can cause elevations in blood pressure and heart rate [ see Warnings and Precautions (5.3) ] . Psychiatric Risks Advise patients and their caregivers that Methylphenidate hydrochloride extended-release tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [ see Warnings and Precautions (5.4) ]. Priapism Advise patients, caregivers, and family members of methylphenidate hydrochloride extended-release tablets-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [ see Warnings and Precautions (5.5) ] . Peripheral Vasculopathy, including Raynaud’s Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms; to report to their health care provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their health care provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release tablets [ see Warnings and Precautions (5.6) ] . Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that Methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss in pediatric patients [ see Warnings and Precautions (5.7) ]. Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during methylphenidate hydrochloride extended-release tablets treatment [see Warnings and Precautions (5.9) ] . Motor and Verbal Tics, and Worsening of Tourette's Syndrome Advise patients that motor and verbal tics and worsening of Tourette's Syndrome may occur during methylphenidate hydrochloride extended-release tablets treatment. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Warnings and Precautions (5.10) ] . Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Methylphenidate hydrochloride extended-release tablets during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Advise methylphenidate hydrochloride extended-release tablets-treated breastfeeding women to monitor their infants for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2) ] . The Medication Guide may also be obtained by calling 1-877-770-3183. Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Rev. 08/2026" ], "spl_medguide": [ "MEDICATION GUIDE MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Tablets (meth\" il fen' i date hye\" droe klor' ide), for oral use, CII What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride extended-release tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride extended-release tablets or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment. o Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give methylphenidate hydrochloride extended-release tablets to anyone else because it may cause death or harm them. See \" What are Methylphenidate hydrochloride extended-release tablets? \" for more information. o Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See \" How should I store Methylphenidate Hydrochloride Extended-Release Tablets? \" for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release tablets. Tell your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any signs of heart problems, such as chest pain, shortness of breath, or fainting during treatment with methylphenidate hydrochloride extended-release tablets. • Increased blood pressure and heart rate. Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets. • Mental problems (psychiatric reactions), including: o worsening behavior or thought problems in people with thought or psychotic disorders o maniac episodes in people with bipolar disorder o new psychotic or manic symptoms in people without bipolar or psychotic disorders Tell your healthcare provider right away if any mental symptoms or problems develop or worsen during treatment with methylphenidate hydrochloride extended-release tablets, including: o greatly increased energy o severe trouble sleeping o racing thoughts o reckless behavior o unusually grand ideas o excessive happiness or irritability o talking more or faster than usual o seeing or hearing things that are not real (hallucinations). See \" What are the possible side effects of methylphenidate hydrochloride extended-release tablets? \" for more information about side effects. What are Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: • Attention deficit hyperactivity disorder (ADHD) in people 6 years of age and older. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. • A sleep disorder called narcolepsy. Methylphenidate hydrochloride extended-release tablets are not recommended for use in children under 6 years of age. Methylphenidate hydrochloride extended-release tablets is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Who should not take Methylphenidate hydrochloride extended-release tablets? Do not take Methylphenidate hydrochloride extended-release tablets if you or your child are: allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets. taking or have taken within the past 14 days, a medicine called a monoamine oxidase inhibitor or MAOI. have a condition called pheochromocytoma (a rare tumor that usually grows in the adrenal glands which are above your kidneys). Before taking methylphenidate hydrochloride extended-release tablets, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child: • have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart problems • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression • have circulation problems in fingers and toes • have had a blockage or narrowing of the intestines • have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness) • have or had repeated uncontrolled movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome • are pregnant or plan to become pregnant. Methylphenidate hydrochloride extended-release tablets may harm the unborn baby. o There is a pregnancy exposure registry for women are exposed to methylphenidate hydrochloride extended-release tablets during pregnancy. The purpose of the registry is to collect information about the health of women exposed to methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/. • are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release tablets. If you breastfeed during treatment with methylphenidate hydrochloride extended-release tablets, monitor your baby for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain. Tell your doctor about all of the medicines that you or your child take including prescription and over-the-counter medicines, vitamins, and herbal supplements. • Methylphenidate hydrochloride extended-release tablets and some medicines may interact with each other and cause serious side effects or affect the way methylphenidate hydrochloride extended-release tablets or other medicines work. Sometimes the doses of other medicines will need to be changed during treatment with Methylphenidate hydrochloride extended-release tablets. • Your healthcare provider will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines. Especially tell your doctor if you or your child takes: • a medicine to treat blood pressure (anti-hypertensive) • risperidone Know the medicines that you or your child takes. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine. Do not start any new medicine during treatment with Methylphenidate hydrochloride extended-release tablets without first talking to your healthcare provider. How should I take Methylphenidate hydrochloride extended-release tablets? • Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed by your or your child’s healthcare provider • Your healthcare provider may change the dose or tell you to stop taking methylphenidate hydrochloride extended-release tablets if needed. • Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours. • Swallow methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Do not split, crush, or chew or crush the extended-release tablets. Tell your healthcare provider if you or your child cannot swallow Methylphenidate hydrochloride extended-release tablets whole. A different medicine may need to be prescribed. • From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD or narcolepsy symptoms. • Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets. • Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups. • If you or your child take too much methylphenidate hydrochloride extended-release tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. What are the possible side effects of Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: See “What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets?” Painful and prolonged erections (priapism). Priapism that may require surgery has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if any of the following signs and symptoms of circulation problems develop during treatment: o fingers or toes feel numb, cool, painful o fingers or toes change color from pale, to blue, to red o sensitivity to temperature in fingers or toes Tell your healthcare provider right away if any unexplained wounds appear on the fingers or toes during treatment with methylphenidate hydrochloride extended-release tablets. • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if your child is not growing or gaining weight as expected. • Eye problems (increased pressure in the eye and glaucoma). Tell your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness. • New or worsening tics or worsening Tourette's syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette's syndrome during treatment with methylphenidate hydrochloride extended-release tablets. The most common side effects of methylphenidate hydrochloride extended-release tablets include: • fast heart beat abnormal heartbeat (palpitations) headache trouble sleeping nervousness sweating a lot decreased appetite dry mouth nausea stomach pain These are not all the possible side effects of methylphenidate hydrochloride extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Methylphenidate hydrochloride extended-release tablets? Store Methylphenidate hydrochloride extended-release tablets in a safe place, like a locked cabinet, and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). Protect from moisture. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Methylphenidate hydrochloride extended-release tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep Methylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children. General information about the safe and effective use of Methylphenidate hydrochloride extended-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them. What are the ingredients in Methylphenidate hydrochloride extended-release tablets? Active ingredient: methylphenidate hydrochloride Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 08/2026" ], "spl_medguide_table": [ "
MEDICATION GUIDEMethylphenidate Hydrochloride Extended-Release Tablets(meth" il fen' i date hye" droe klor' ide), for oral use, CII
What is the most important information I should know aboutMethylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride extended-release tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride extended-release tablets or when it is used in ways that are not approved, such as snorting or injection. o Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment. o Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give methylphenidate hydrochloride extended-release tablets to anyone else because it may cause death or harm them. See " What are Methylphenidate hydrochloride extended-release tablets?" for more information. o Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See " How should I store Methylphenidate Hydrochloride Extended-Release Tablets?" for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release tablets. Tell your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any signs of heart problems, such as chest pain, shortness of breath, or fainting during treatment with methylphenidate hydrochloride extended-release tablets. • Increased blood pressure and heart rate. Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets. • Mental problems (psychiatric reactions), including: o worsening behavior or thought problems in people with thought or psychotic disorders o maniac episodes in people with bipolar disorder o new psychotic or manic symptoms in people without bipolar or psychotic disorders Tell your healthcare provider right away if any mental symptoms or problems develop or worsen during treatment with methylphenidate hydrochloride extended-release tablets, including: o greatly increased energy o severe trouble sleeping o racing thoughts o reckless behavior o unusually grand ideas o excessive happiness or irritability o talking more or faster than usual o seeing or hearing things that are not real (hallucinations). See " What are the possible side effects of methylphenidate hydrochloride extended-release tablets?" for more information about side effects.
What are Methylphenidate hydrochloride extended-release tablets?Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: • Attention deficit hyperactivity disorder (ADHD) in people 6 years of age and older. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. • A sleep disorder called narcolepsy. Methylphenidate hydrochloride extended-release tablets are not recommended for use in children under 6 years of age. Methylphenidate hydrochloride extended-release tablets is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.
Who should not take Methylphenidate hydrochloride extended-release tablets?Do not take Methylphenidate hydrochloride extended-release tablets if you or your child are:allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets.taking or have taken within the past 14 days, a medicine called a monoamine oxidase inhibitor or MAOI.have a condition called pheochromocytoma (a rare tumor that usually grows in the adrenal glands which are above your kidneys).
Before taking methylphenidate hydrochloride extended-release tablets, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:• have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart problems • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression • have circulation problems in fingers and toes • have had a blockage or narrowing of the intestines • have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness) • have or had repeated uncontrolled movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome • are pregnant or plan to become pregnant. Methylphenidate hydrochloride extended-release tablets may harm the unborn baby. o There is a pregnancy exposure registry for women are exposed to methylphenidate hydrochloride extended-release tablets during pregnancy. The purpose of the registry is to collect information about the health of women exposed to methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.• are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release tablets. If you breastfeed during treatment with methylphenidate hydrochloride extended-release tablets, monitor your baby for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain.Tell your doctor about all of the medicines that you or your child take including prescription and over-the-counter medicines, vitamins, and herbal supplements. • Methylphenidate hydrochloride extended-release tablets and some medicines may interact with each other and cause serious side effects or affect the way methylphenidate hydrochloride extended-release tablets or other medicines work. Sometimes the doses of other medicines will need to be changed during treatment with Methylphenidate hydrochloride extended-release tablets. • Your healthcare provider will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines. Especially tell your doctor if you or your child takes:• a medicine to treat blood pressure (anti-hypertensive) • risperidone Know the medicines that you or your child takes. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.Do not start any new medicine during treatment with Methylphenidate hydrochloride extended-release tablets without first talking to your healthcare provider.
How shouldI take Methylphenidate hydrochloride extended-release tablets? • Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed by your or your child’s healthcare provider • Your healthcare provider may change the dose or tell you to stop taking methylphenidate hydrochloride extended-release tablets if needed. • Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours. • Swallow methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Do not split, crush, or chew or crush the extended-release tablets. Tell your healthcare provider if you or your child cannot swallow Methylphenidate hydrochloride extended-release tablets whole. A different medicine may need to be prescribed. • From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD or narcolepsy symptoms. • Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets. • Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups. • If you or your child take too much methylphenidate hydrochloride extended-release tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects ofMethylphenidate hydrochloride extended-release tablets?Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including:See “What is the most important information I should know aboutMethylphenidate hydrochloride extended-release tablets?”Painful and prolonged erections (priapism). Priapism that may require surgery has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if any of the following signs and symptoms of circulation problems develop during treatment: o fingers or toes feel numb, cool, painful o fingers or toes change color from pale, to blue, to red o sensitivity to temperature in fingers or toes Tell your healthcare provider right away if any unexplained wounds appear on the fingers or toes during treatment with methylphenidate hydrochloride extended-release tablets. • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if your child is not growing or gaining weight as expected. • Eye problems (increased pressure in the eye and glaucoma). Tell your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness. • New or worsening tics or worsening Tourette's syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette's syndrome during treatment with methylphenidate hydrochloride extended-release tablets. The most common side effects of methylphenidate hydrochloride extended-release tablets include: • fast heart beat abnormal heartbeat (palpitations)headachetrouble sleepingnervousnesssweating a lotdecreased appetitedry mouthnauseastomach pain These are not all the possible side effects of methylphenidate hydrochloride extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I storeMethylphenidate hydrochloride extended-release tablets?Store Methylphenidate hydrochloride extended-release tablets in a safe place, like a locked cabinet, and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).Protect from moisture.Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Methylphenidate hydrochloride extended-release tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.KeepMethylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use ofMethylphenidate hydrochloride extended-release tablets.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them.
What are the ingredients inMethylphenidate hydrochloride extended-release tablets?Active ingredient: methylphenidate hydrochloride Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. Manufactured by:Granules Pharmaceuticals Inc.Chantilly, VA 20151
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